Swissmedic Schweizerisches Heilmittelinstitut Hallerstrasse 7 CH-3000 Bern www.swissmedic.ch PSUR und E2E/RMP-Updates 2nd Follow-up Information Meeting.

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Presentation transcript:

Swissmedic Schweizerisches Heilmittelinstitut Hallerstrasse 7 CH-3000 Bern PSUR und E2E/RMP-Updates 2nd Follow-up Information Meeting with Workshops – Step 3 Rudolf Stoller 16th March 2011

2 Overview 1.PSUR und E2E/RMP-Updates: before Step 3 2.PSUR “Application Type” 3.E2E/RMP-Update Submission 4.PSUR Form 5.Structure PSUR eCTD-Submission 6.Paper vs eCTD-Submission 7.PSUR Process: eCTD related Changes

3 PSUR und E2E/RMP-Updates before eCTD Step 3 (l) PSURs  About 300 submissions: 1-year rhythm  When a PSUR, submitted as part of the PSUR Programme, served also as a supporting document for a Product Information Variation (VAR-PI)  VAR-PI application reviewed by AMS-RM (Division Safety of Medicines, Unit Risk Management)  eCTD Step 3: PSUR process simplified, PSUR Form revised, requested as working document (.doc)

4 PSUR und E2E/RMP-Updates before eCTD Step 3 (ll) E2E/RMP-Updates  Reviewed by AMS-RM only when „original“ RMP evaluated by AMS-RM  Total number of RMPs evaluated by AMS-RM is increasing  Increasing number of RMP-Updates for review

5 Overview 1.PSUR und E2E/RMP-Updates: before Step 3 2.PSUR “Application Type” 3.E2E/RMP-Update Submission 4.PSUR Form 5.Structure PSUR eCTD-Submission 6.Paper vs eCTD-Submission 7.PSUR Process: eCTD related Changes

6 PSUR „Application Type“ (Envelope) (l) „PSUR“ submitted with PSUR Form  PSUR Art. 34 VAM (authorization received within the last 5 years)  PSUR Art. 34 reference Art. 17, Para. 2 VAM (major changes within the last 5 years)  PSUR Art. 16, Para. 1 TPA (commitments)  Use this application type when submitted as part of the PSUR Program

7 PSUR „Application Type“ (Envelope) (ll) „VAR-PI“ (Product Information Variation)  When Product Information Variation (VAR-PI) is based on a PSUR submitted as part of the PSUR Program  Use Form “Application for Marketing Authorisation and Variation” „Supplemental Info“  When submitted outside of the PSUR Program (non- VAM and non-TPA based PSUR) and for other reasons  Mention the reason for submission in the Cover Letter

8 Overview 1.PSUR und E2E/RMP-Updates: before Step 3 2.PSUR “Application Type” 3.E2E/RMP-Update Submission 4.PSUR Form 5.Structure PSUR eCTD-Submission 6.Paper vs eCTD-Submission 7.PSUR Process: eCTD related Changes

9 E2E/RMP-Update Submission (Envelope) „PSUR“ (Application Type)  If submitted as part of the regular PSUR Program  Submit only when there are relevant changes to the previous version  Mention the differences from the previous version in the PSUR Form „Supplemental Info“ (Application Type)  If not submitted as part of the regular PSUR Program  Mention the reason for submission in the Cover Letter

10 Overview 1.PSUR und E2E/RMP-Updates: before Step 3 2.PSUR “Application Type” 3.E2E/RMP-Update Submission 4.PSUR Form 5.Structure PSUR eCTD-Submission 6.Paper vs eCTD-Submission 7.PSUR Process: eCTD related Changes

11 PSUR Form (eCTD workingdocument) (l)

12 PSUR Form (eCTD workingdocument) (ll)

13 Overview 1.PSUR und E2E/RMP-Updates: before Step 3 2.PSUR “Application Type” 3.E2E/RMP-Update Submission 4.PSUR Form 5.Structure PSUR eCTD-Submission 6.Paper vs eCTD-Submission 7.PSUR Process: eCTD related Changes

14 Structure of a PSUR eCTD-Submission eCTD ModulDocument 1.0Cover Letter FORM PSUR Comparison EU-SPC vs CH-FI Company Core Data Sheet 1.3.4Information for Professionals from Other Countries (EU SPC) 1.8.2E2E-(RMP) Update 5.3.6PSUR

15 Overview 1.PSUR und E2E/RMP-Updates: before Step 3 2.PSUR “Application Type” 3.E2E/RMP-Update Submisssion 4.PSUR Form 5.Structure PSUR eCTD-Submission 6.Paper vs eCTD-Submission 7.PSUR Process: eCTD related Changes

16 PSUR-Submission: Paper vs eCTD ActivityPapereCTD Notification from DBW (documentation) Administrative Work comparable PSUR Doc order / return not needed Evaluation Report

17 Overview 1.PSUR und E2E/RMP-Updates: before Step 3 2.PSUR “Application Type” 3.E2E/RMP-Update Submission 4.PSUR Form 5.Structure PSUR eCTD-Submission 6.Paper vs eCTD-Submission 7.PSUR Process: eCTD related Changes

18 PSUR Process: eCTD related Changes Summary  Application Type „PSUR“ when submitted as part of the PSUR Program  AMS-RM  VAR-PI based on a PSUR submitted as part of the PSUR Program  2 Applications / Sequences: PSUR und VAR-PI  AMS-RM and ZL  PSUR Form requested as working document (.doc)  E2E/RMP-Updates  Submitted with PSUR  Relevant changes to previous version reviewed by AMS-RM

19 Thank you for your attention Rudolf StollerDr. Rosemarie Sift CarterSwissmedic